MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-12-08 for HCYS HOMOCYSTEINE ENZYMATIC ASSAY 06542921190 manufactured by Roche Diagnostics.
[61737070]
(b)(6). (b)(4). The customer has discarded the reagent.
Patient Sequence No: 1, Text Type: N, H10
[61737071]
The customer initially questioned quality control (qc) results when they received new reagent lot number 173121 for the hcys homocysteine enzymatic assay (hcys). The customer performed comparison tests using the new reagent lot and the old reagent lot with patient samples and no differences were observed. Afterwards, the customer began to use the new reagent lot. Over time, their qc results began to drift and the customer decided not to run hcys tests with reagent lot 173121 until they received new reagents. Around this time the customer received communication from the manufacturer about reagent lot 173121. Due to this communication, the customer reviewed the median of the patient results tested for hcys and noticed the median had dropped. The customer concluded that they may have released incorrect, low hcys results. The customer has contacted medical personnel and informed them that the actual hcys patient results may not be as low as the results indicate. No specific results were provided and no patient information was provided. The customer provided a median result from (b)(6) 2016 of 13. 261 umol/l and a median result from (b)(6) 2016 of 9. 652 umol/l. No adverse event occurred. The cobas 8000 c (701) module serial number was not provided. The customer has discarded the reagent.
Patient Sequence No: 1, Text Type: D, B5
[63926434]
An issue with reagent lot 173121 resulting in under recovery of quality control and patient sample results has been confirmed by the investigation. The hcys lot number in this case is not distributed in the united states, therefore, this issue does not affect customers in the united states.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01916 |
| MDR Report Key | 6154282 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-08 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-11-21 |
| Date Mfgr Received | 2016-11-22 |
| Date Added to Maude | 2016-12-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HCYS HOMOCYSTEINE ENZYMATIC ASSAY |
| Generic Name | HOMOCYSTEINE TEST |
| Product Code | LPS |
| Date Received | 2016-12-08 |
| Model Number | NA |
| Catalog Number | 06542921190 |
| Lot Number | 173121 |
| ID Number | NA |
| Device Expiration Date | 2017-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-08 |